Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 3: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Dexmedetomidine infusion: Infusion of dexmedetomidine, 1 mcg/kg/min over 10 minsfollowed by 0.5mcg/kg/h for achieving satisfactory sedation during ERCP
Control Intervention1: Propofol i
Sponsors
Amrita Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients with ASA I to III, belonging to age group 18-65 years scheduled for elective ERCP procedure.
Exclusion criteria
Exclusion criteria: 1. Duration of procedure >2 hours 2. Severe Cardiac, Pulmonary, CNS and Renal disorders 3. Allergic to study medications. 4.Habituation to Sedative drugs. 5. Morbid obesity. 6.Refusal to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken to achieve satisfactory sedation Ramsay sedation Score (RSS 3-4) using an infusion of dexmedetomidine versus propofol infusionTimepoint: Start of infusion until RSS of 3-4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of times additional boluses are administered and dosing needed. 2.To note the time taken for recovery (from discontinuation of the study drug till achieving Modified Aldrete Score 9-10 3. To look for incidence ofadverse effects hypotension (SBPâ?¤90mm Hg), bradycardia (HRâ?¤50 bpm), desaturation (SpO2â?¤92 for 10sec) and apnoea (no spontaneous breaths for 10sec) and any interventions. 4. To assess patient and endoscopist satisfaction by a scoring system . Timepoint: Points in time needing additional intervention during the procedure | — |
Countries
India
Contacts
Public ContactDrRoopa Manchinabele Nagabhushan
Amrita Institute of Medical Sciences ad Research Centre
Outcome results
None listed